The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Coonrad/morrey Total Elbow. Model 32-8105 Series.
| Device ID | K001989 |
| 510k Number | K001989 |
| Device Name: | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Laura D Williams |
| Correspondent | Laura D Williams ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-29 |
| Decision Date | 2000-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024274204 | K001989 | 000 |
| 00889024274006 | K001989 | 000 |
| 00889024273993 | K001989 | 000 |
| 00889024273986 | K001989 | 000 |
| 00889024273979 | K001989 | 000 |
| 00889024273962 | K001989 | 000 |
| 00889024273955 | K001989 | 000 |
| 00889024273948 | K001989 | 000 |
| 00889024273924 | K001989 | 000 |
| 00889024508590 | K001989 | 000 |
| 00889024273931 | K001989 | 000 |
| 00889024639782 | K001989 | 000 |
| 00889024639775 | K001989 | 000 |
| 00889024639768 | K001989 | 000 |
| 00889024274013 | K001989 | 000 |
| 00889024274020 | K001989 | 000 |
| 00889024274037 | K001989 | 000 |
| 00889024274198 | K001989 | 000 |
| 00889024274181 | K001989 | 000 |
| 00889024274174 | K001989 | 000 |
| 00889024274167 | K001989 | 000 |
| 00889024274150 | K001989 | 000 |
| 00889024274143 | K001989 | 000 |
| 00889024274136 | K001989 | 000 |
| 00889024274129 | K001989 | 000 |
| 00889024274112 | K001989 | 000 |
| 00889024274075 | K001989 | 000 |
| 00889024274068 | K001989 | 000 |
| 00889024274051 | K001989 | 000 |
| 00889024274044 | K001989 | 000 |
| 00889024639751 | K001989 | 000 |